Pharmacy preparation organisation

The costs of materials, duration of preparation, quality control, investment in premises, training, quality assurance et cetera determine the basic cost of pharmacy preparation. As with the reimbursement of licensed medicines there is a distinction between in-patient and out-patient supply. Pharmacy preparations used in hospitals could be considered to be part of the reimbursement for the therapy as a whole. Anyhow, the hospital pharmacist normally has to find his payment within the hospital organisation. In community pharmacy most pharmacy preparations are reimbursed by the health insurer, according to the Tax price with a surcharge according to the performance cost system. Reimbursement for... 

The output and associated risk analysis justifying the approach should be documented and endorsed by the organisation s quality unit and senior management. Additionally, this information should be communicated to stakeholders for their information and to ensure their support. Again reference is given to Sect. 2.2 for an example how to perform this for pharmacy preparations. 

Pharmacy preparation is essentially a clinical process if it is meant (see Sect. 3.2) to provide patients with the medicines they need and which are not available as licensed medicines. ISO, especially its particularisation to health care EN 15224, can be applied to healthcare organisations. So it can be applied to pharmacies as well. The EN 15224 consideration that pharmaceuticals to be regulated elsewhere applies to licensed medicines but not to pharmacy preparations. 

This section is about common elements of a PQS, with focus on pharmacy preparation as a process and community and hospital pharmacies as the organisations. For industrial production the same principles are valid but more elaborate literature exists. Most elements are common to any Quality Management System and are for instance described and strucmred in ISO 9001 (see Sect 35.7.2). Some elements are closely related and are therefore seen as pharmaceutical quality subsystems. They are combined in mie subsection, for instance internal audits, inspection and external audits... 

Until about 1900 pharmacists prepared all medicinal products in their own pharmacy, mostly with help of self-trained assistants. With the upcoming pharmaceutical industry more complex organisations came to life and more pharmacists were needed apart from the pharmacist/owner. The introduction of managers and... 

In 2012 the German Organisation of Hospital Pharmacy published the ADKA guideline on Aseptic Preparation and Quality Control of ready-to-administer parenterals. All precautions to be taken to keep the products sterile are described systematically [9]. 

In larger preparation units, for example the hospital pharmacy, often an automated system for the drafting of BPIs is used. Within such a system, it is usually possible to create one or more standard layouts, adjusted to the needs of the specific organisation and adapted to the type of preparation or the pharmaceutical form. 

Establishment of a quality manual according to the requirements of a standard has the disadvantage that the manual usually does not complies when the organisation should also adhere with another standard. Actually, a PQS, and thus a quality manual, including the preparation activities as well as the clinical processes of a pharmacy is not easy to structure. See further Sect. 35.7 for possible solutions and Sect. 35.7.5 for a practice advice when working with the 7 Pillars model. 

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